Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm)

This study has been completed.

First Received: June 2, 2006 Last Updated: May 12, 2008 History of Changes

Sponsored by:	LifeScan
Information provided by:	LifeScan
ClinicalTrials.gov Identifier:	NCT00333853

Purpose

Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).

Condition	Intervention
Diabetes	Device: OneTouch(r) UltraSmart(r)

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Active Control, Open Label, Parallel Assignment, Randomized
Official Title:	Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes

Further study details as provided by LifeScan:

Primary Outcome Measures:

Hemoglobin A1c (HbA1c)

Secondary Outcome Measures:

Measured hypoglycemia

Estimated Enrollment:	250
Study Start Date:	August 2003
Estimated Study Completion Date:	June 2005

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%.
The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs).
The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment).
Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own.

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333853

Locations

United States, California
Children's Hospital, Los Angeles
Los Angeles, California, United States, 90027
Diabetes and Endocrine Associates
La Jolla, California, United States, 92037
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97239

Sponsors and Collaborators

LifeScan

Investigators

Principal Investigator:

Lori Laffel, MD, MPH

Joslin Diabetes Center

More Information

Publications of Results:

Laffel LM, Hsu WC, McGill JB, Meneghini L, Volkening LK. Continued use of an integrated meter with electronic logbook maintains improvements in glycemic control beyond a randomized, controlled trial. Diabetes Technol Ther. 2007 Jun;9(3):254-64.

Responsible Party:	( LifeScan, Inc. )
Study ID Numbers:	DDI 70-97017-17
Study First Received:	June 2, 2006
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00333853 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on March 16, 2009